Trial Outcomes & Findings for Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension (NCT NCT01099774)

Results Overview

Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

597 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2019-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Bimatoprost 0.03% Formulation B Ophthalmic Solution Bimatoprost 0.03% Formulation B Ophthalmic Solution	Bimatoprost 0.03% Ophthalmic Solution Bimatoprost 0.03% Ophthalmic Solution
Overall Study STARTED	302	295
Overall Study COMPLETED	296	289
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimatoprost 0.03% Formulation B Ophthalmic Solution n=302 Participants Bimatoprost 0.03% Formulation B Ophthalmic Solution	Bimatoprost 0.03% Ophthalmic Solution n=295 Participants Bimatoprost 0.03% Ophthalmic Solution	Total n=597 Participants Total of all reporting groups
Age, Customized <45 years	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Age, Customized Between 45 and 65 years	159 Participants n=5 Participants	134 Participants n=7 Participants	293 Participants n=5 Participants
Age, Customized >65 years	135 Participants n=5 Participants	150 Participants n=7 Participants	285 Participants n=5 Participants
Sex: Female, Male Female	170 Participants n=5 Participants	181 Participants n=7 Participants	351 Participants n=5 Participants
Sex: Female, Male Male	132 Participants n=5 Participants	114 Participants n=7 Participants	246 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Per Protocol Population: All randomized patients who did not have a protocol violation that significantly affected the conduct or the results of the trial.

Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.

Outcome measures

Outcome measures
Measure	Bimatoprost 0.03% Formulation B Ophthalmic Solution n=295 Participants Bimatoprost 0.03% Formulation B Ophthalmic Solution	Bimatoprost 0.03% Ophthalmic Solution n=291 Participants Bimatoprost 0.03% Ophthalmic Solution
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 Baseline Hour 0	24.90 Millimeters of Mercury (mmHg) Standard Deviation 2.364	24.86 Millimeters of Mercury (mmHg) Standard Deviation 2.161
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 Baseline Hour 2	23.79 Millimeters of Mercury (mmHg) Standard Deviation 2.992	23.78 Millimeters of Mercury (mmHg) Standard Deviation 2.753
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 Baseline Hour 8	22.81 Millimeters of Mercury (mmHg) Standard Deviation 3.168	22.80 Millimeters of Mercury (mmHg) Standard Deviation 3.301
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 Change from Baseline Hour 0 at Week 12	-7.49 Millimeters of Mercury (mmHg) Standard Deviation 2.900	-7.77 Millimeters of Mercury (mmHg) Standard Deviation 3.029
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 Change from Baseline Hour 2 at Week 12	-7.06 Millimeters of Mercury (mmHg) Standard Deviation 3.333	-7.11 Millimeters of Mercury (mmHg) Standard Deviation 3.192
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 Change from Baseline Hour 8 at Week 12	-5.93 Millimeters of Mercury (mmHg) Standard Deviation 3.432	-6.06 Millimeters of Mercury (mmHg) Standard Deviation 3.602

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Intent to Treat Population: all randomized patients.

Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.

Outcome measures

Outcome measures
Measure	Bimatoprost 0.03% Formulation B Ophthalmic Solution n=302 Participants Bimatoprost 0.03% Formulation B Ophthalmic Solution	Bimatoprost 0.03% Ophthalmic Solution n=295 Participants Bimatoprost 0.03% Ophthalmic Solution
Average Eye IOP at Week 12 Baseline Hour 8	22.31 Millimeters of Mercury (mmHg) Standard Deviation 2.974	22.29 Millimeters of Mercury (mmHg) Standard Deviation 3.110
Average Eye IOP at Week 12 Week 12 Hour 0	17.25 Millimeters of Mercury (mmHg) Standard Deviation 2.804	16.96 Millimeters of Mercury (mmHg) Standard Deviation 2.886
Average Eye IOP at Week 12 Week 12 Hour 2	16.51 Millimeters of Mercury (mmHg) Standard Deviation 2.900	16.55 Millimeters of Mercury (mmHg) Standard Deviation 2.863
Average Eye IOP at Week 12 Week 12 Hour 8	16.64 Millimeters of Mercury (mmHg) Standard Deviation 2.820	16.59 Millimeters of Mercury (mmHg) Standard Deviation 2.735
Average Eye IOP at Week 12 Baseline Hour 0	24.53 Millimeters of Mercury (mmHg) Standard Deviation 2.196	24.46 Millimeters of Mercury (mmHg) Standard Deviation 2.019
Average Eye IOP at Week 12 Baseline Hour 2	23.30 Millimeters of Mercury (mmHg) Standard Deviation 2.848	23.26 Millimeters of Mercury (mmHg) Standard Deviation 2.613

PRIMARY outcome

Timeframe: Week 6

Population: Intent to Treat Population: all randomized patients.

Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.

Outcome measures

Outcome measures
Measure	Bimatoprost 0.03% Formulation B Ophthalmic Solution n=302 Participants Bimatoprost 0.03% Formulation B Ophthalmic Solution	Bimatoprost 0.03% Ophthalmic Solution n=295 Participants Bimatoprost 0.03% Ophthalmic Solution
Average Eye IOP at Week 6 Week 6 Hour 0	17.16 Millimeters of Mercury (mmHg) Standard Deviation 2.967	17.08 Millimeters of Mercury (mmHg) Standard Deviation 2.957
Average Eye IOP at Week 6 Week 6 Hour 2	16.52 Millimeters of Mercury (mmHg) Standard Deviation 2.855	16.45 Millimeters of Mercury (mmHg) Standard Deviation 2.766
Average Eye IOP at Week 6 Week 6 Hour 8	16.56 Millimeters of Mercury (mmHg) Standard Deviation 2.838	16.32 Millimeters of Mercury (mmHg) Standard Deviation 2.702

PRIMARY outcome

Timeframe: Week 2

Population: Intent to Treat Population: all randomized patients.

Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.

Outcome measures

Outcome measures
Measure	Bimatoprost 0.03% Formulation B Ophthalmic Solution n=302 Participants Bimatoprost 0.03% Formulation B Ophthalmic Solution	Bimatoprost 0.03% Ophthalmic Solution n=295 Participants Bimatoprost 0.03% Ophthalmic Solution
Average Eye IOP at Week 2 Week 2 Hour 0	17.40 Millimeters of Mercury (mmHg) Standard Deviation 2.732	17.14 Millimeters of Mercury (mmHg) Standard Deviation 2.677
Average Eye IOP at Week 2 Week 2 Hour 2	16.68 Millimeters of Mercury (mmHg) Standard Deviation 2.759	16.43 Millimeters of Mercury (mmHg) Standard Deviation 2.581
Average Eye IOP at Week 2 Week 2 Hour 8	16.61 Millimeters of Mercury (mmHg) Standard Deviation 2.766	16.39 Millimeters of Mercury (mmHg) Standard Deviation 2.795

Adverse Events

Bimatoprost 0.03% Formulation B Ophthalmic Solution

Serious events: 2 serious events

Other events: 72 other events

Deaths: 0 deaths

Bimatoprost 0.03% Ophthalmic Solution

Serious events: 5 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bimatoprost 0.03% Formulation B Ophthalmic Solution n=301 participants at risk Bimatoprost 0.03% Formulation B Ophthalmic Solution	Bimatoprost 0.03% Ophthalmic Solution n=295 participants at risk Bimatoprost 0.03% Ophthalmic Solution
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.33% 1/301	0.00% 0/295
Injury, poisoning and procedural complications Spinal Compression Fracture	0.33% 1/301	0.00% 0/295
Cardiac disorders Atrial Fibrillation	0.00% 0/301	0.34% 1/295
Nervous system disorders Convulsion	0.00% 0/301	0.34% 1/295
General disorders Death	0.00% 0/301	0.34% 1/295
Nervous system disorders Syncope	0.00% 0/301	0.34% 1/295
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Carcinoma	0.00% 0/301	0.34% 1/295

Other adverse events

Other adverse events
Measure	Bimatoprost 0.03% Formulation B Ophthalmic Solution n=301 participants at risk Bimatoprost 0.03% Formulation B Ophthalmic Solution	Bimatoprost 0.03% Ophthalmic Solution n=295 participants at risk Bimatoprost 0.03% Ophthalmic Solution
Eye disorders Conjunctival Hyperaemia	23.9% 72/301	26.1% 77/295

Additional Information

Therapeutic Area Head

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Publication restrictions are in place

Restriction type: OTHER